Status:
TERMINATED
NOGO-A in Multiple Sclerosis FTIH
Lead Sponsor:
GlaxoSmithKline
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth. The trial is expected to involve approximately 36 patients. The study objective i...
Detailed Description
This is a phase I study of GSK1223249. The study design is randomized, placebo-controlled, double-blind, sequential dose escalation, single dose administration. Approximately 36 patients with relapsin...
Eligibility Criteria
Inclusion
- Suitable as determined by the Principal Investigator, based on his/her overall evaluation. A patient with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Diagnosed with a relapsing form of MS defined as either
- Relapsing Remitting MS according to revised McDonald Criteria \[McDonald, 2001; Polman, 2005\] plus any one of the following:
- Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
- OR
- Secondary Progressive MS, plus any one of the following: Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
- Expanded Disability Status Scale (EDSS) score ≤5.5
- Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Exclusion
- Abnormal baseline blood tests
- Treatment with interferon-beta-1b (Betaferon), interferon-beta-1a (Rebif or Avonex), or glatiramer acetate (Copaxone) within 90 days of dosing.
- Treatment with methylprednisolone or any other systemic steroids within 60 days of dosing.
- Treatment within the past 12 months or currently with any of the following agents: cyclosporine, azathioprine, methotrexate, cladribine, natalizumab (Tysabri®) or other monoclonal antibodies, murine protein, T-cell vaccination, plasmapheresis, IVI gG, ,stem cell transplantation.
- History of intolerance to acetominophen, ibuprofen, naproxen or any other non-steroidal anti-inflammatory agent which would preclude use of at least one of these during the study.
- Previous history of anaphylaxis, severe allergic reaction, or hypersensitivity to albumin or a protein-based therapeutic, including natalizumab (Tysabri) or any other monoclonal antibody. History of hypersensitivity to any of the components of the formulation.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
- Patients with evidence of dementia or psychiatric illness which, in the Investigator's opinion, is likely to prevent them from a full understanding of and/or compliance with the study requirements and procedures.
Key Trial Info
Start Date :
February 11 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2010
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01424423
Start Date
February 11 2010
End Date
August 26 2010
Last Update
September 20 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Heidelberg, Victoria, Australia, VIC 3084